MIBC

Osisko Metals Reports Preliminary Metallurgical Testwork Results From Gaspé Copper

Retrieved on: 
Mardi, avril 16, 2024

The crushed material was blended and split into 24 kg sub-lots, each sub-lot was rotary split into 2 kg charges.

Key Points: 
  • The crushed material was blended and split into 24 kg sub-lots, each sub-lot was rotary split into 2 kg charges.
  • Metallurgical samples comprising drill core were crushed, split and sub-sampled for comminution testwork and head assays.
  • Copper was analyzed using atomic adsorption (AA) spectroscopy, and molybdenum and silver by inductively coupled plasma – optical emission spectroscopy (ICP-OES).
  • A composite sample was initially tested with average copper grade to determine the optimal grind size for further flotation tests.

Recurrence Data for Narrow Band Imaging™ (NBI™) Technology Show Value in the Fight Against Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Mercredi, avril 24, 2024

CENTER VALLEY, Pa., April 24, 2024 /PRNewswire/ -- Olympus, a global medical technology company committed to making people's lives healthier, safer, and more fulfilling, announced today data showing that the use of Narrow Band Imaging (NBI) technology with patients with non-muscle invasive bladder cancer (NMIBC) led to 37% less likelihood of recurrence over 12-35 months.1 

Key Points: 
  • As reported by the American Cancer Society, bladder cancer has one of the highest recurrence rates.2 Additionally, "recurrence and progression to muscle-invasive bladder cancer (MIBC) is highly variable, depending on tumor classification and grade at diagnosis.
  • For example, in patients diagnosed with low-grade noninvasive urothelial carcinoma (Ta), recurrence rates range from 30% to 60% at 5 years; however, the risk of progression to MIBC is ≤5%.
  • In contrast, patients with high-grade urothelial carcinoma invading into the lamina propria (T1) have progression rates of 30% to 70%."
  • NBI technology will also be available for demo at the Olympus booth at the American Urological Association (AUA) conference, May 3-6, 2024, in San Antonio, TX.

Natera Announces Positive Surveillance Analysis from the Randomized Phase III IMvigor011 Trial in Muscle-Invasive Bladder Cancer

Retrieved on: 
Vendredi, avril 5, 2024

The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.

Key Points: 
  • The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.
  • Sponsored by Genentech, a member of the Roche group, IMvigor011 is a global, double-blind, randomized, Phase III trial, in which high-risk MIBC patients are serially tested with Signatera for up to 12 months post cystectomy.
  • Patients who test Signatera MRD-positive at any point during the 12-month surveillance window are randomized to the anti-PDL1 atezolizumab (Tecentriq®) vs. placebo.
  • “We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients.

Aura Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights

Retrieved on: 
Mercredi, mars 27, 2024

Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors to preserve the function of the afflicted organ with cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights.

Key Points: 
  • Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors to preserve the function of the afflicted organ with cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights.
  • The primary endpoint is time to tumor progression when the last patient completes 15 months of follow up.
  • As of December 31, 2023, Aura had cash and cash equivalents and marketable securities totaling $226.2 million.
  • General and administrative expenses include $1.2 million and $1.1 million of stock-based compensation for the three months ended December 31, 2023 and 2022, respectively.

Enhancing Leadership in Gynecology, Asieris Pharmaceuticals Appoints Sophia Cao to Lead the Newly-Established Women's Health Business Unit, Accelerating Strategic Expansion

Retrieved on: 
Mardi, janvier 9, 2024

This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.

Key Points: 
  • This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.
  • Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women's health.
  • In November 2020, the World Health Organization (WHO) released a Global Strategy to Accelerate the Elimination of Cervical Cancer.
  • To further deliver its strategic vision and commitment in the realm of women's health, Asieris Pharmaceuticals has announced the establishment of the Women's Health Business Unit.

New Data by Breast Cancer Canada Reveals Almost 3 in 4 Canadians (73%) Turn to Search Engines to Understand a Diagnosis from Their Doctor

Retrieved on: 
Mercredi, décembre 6, 2023

After receiving a diagnosis from their doctor, almost 3 in 4 Canadians (73%) would turn to a search engine to further understand their diagnosis and options for treatment.

Key Points: 
  • After receiving a diagnosis from their doctor, almost 3 in 4 Canadians (73%) would turn to a search engine to further understand their diagnosis and options for treatment.
  • “Canadians often turn to search engines to gather information about their breast cancer diagnosis.
  • Charlene Newland was advised not to turn to the internet for answers after her Stage 2 breast cancer diagnosis at 33 years old.
  • ** New Data by Breast Cancer Canada Reveals Almost 3 in 4 Canadians (73%) Turn to Search Engines to Understand a Diagnosis from Their Doctor.

CatalYm commences Dosing in a Phase 2 Study with Visugromab in Combination with Neoadjuvant Immunotherapy in Treatment-naive Muscle Invasive Bladder Cancer Patients

Retrieved on: 
Jeudi, octobre 26, 2023

CatalYm today announced that the first patient has been dosed in the Phase 2 clinical trial, GDFather-NEO ( NCT06059547 ), evaluating its lead anti-GDF-15 antibody candidate, visugromab, in combination with neoadjuvant immunotherapy (nivolumab, aPD-1 inhibitor) in muscle invasive bladder cancer (MIBC).

Key Points: 
  • CatalYm today announced that the first patient has been dosed in the Phase 2 clinical trial, GDFather-NEO ( NCT06059547 ), evaluating its lead anti-GDF-15 antibody candidate, visugromab, in combination with neoadjuvant immunotherapy (nivolumab, aPD-1 inhibitor) in muscle invasive bladder cancer (MIBC).
  • The exploratory study expands visugromab’s clinical Phase 2 evaluation to a therapeutic front-line setting, building on the positive results from the ongoing GDFather-2 ( NCT04725474 ) trial in last-line metastatic patients with a range of advanced, treatment-resistant solid tumors.
  • In addition, the study will provide data on potential response-predictive biomarkers for patient stratification.
  • The trial will be led from Milan, Italy, and will enroll 30 patients in a 1:1 setting at four sites in Italy.

New Health Economic analysis in France concludes there is insignificant cost difference between White Light and Blue Light Cystoscopy use when applying ccAFU guidelines

Retrieved on: 
Vendredi, octobre 6, 2023

This health economic analysis aims to assess the financial impact of widely adopting Blue Light Cystoscopy (BLC®) as recommended in the French ccAFU guidelines.

Key Points: 
  • This health economic analysis aims to assess the financial impact of widely adopting Blue Light Cystoscopy (BLC®) as recommended in the French ccAFU guidelines.
  • The most recent ccAFU (Comité de cancérologie de l'Association française d'urologie) guidelines recommend the use of BLC in a number of different positions in the care pathway for NMIBC.
  • a large public hospital implementing the specific BLC recommendations within the ccAFU guidelines for 300 new patients per year and 2.)
  • Recurrence rates for BLC-assisted patients were estimated by applying a single overall hazard ratio estimate to all patient groups.

Natera Submits First PMA Module to the FDA for Signatera™

Retrieved on: 
Lundi, octobre 2, 2023

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the submission of the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, as a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC).

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the submission of the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, as a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC).
  • This module, submitted on September 28, included the required documentation regarding Natera’s manufacturing and quality control systems, which the Company expects will support all future indications for Signatera as well as other Natera products.
  • The remaining modules for the Signatera MIBC indication, including software, analytical and clinical validation data, are expected to be submitted through 2025 upon completion of the ongoing registrational trial.
  • “With this initial step towards a PMA for Signatera, we are continuing to build on our longstanding engagement with the FDA,” said Steve Chapman, chief executive officer of Natera.

Natera Announces New Signatera™ MRD Data at 2023 AACR Annual Meeting

Retrieved on: 
Vendredi, avril 14, 2023

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced new data on its Signatera molecular residual disease (MRD) test being presented at the annual meeting of the American Association for Cancer Research (AACR) taking place April 14 – 19, 2023.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced new data on its Signatera molecular residual disease (MRD) test being presented at the annual meeting of the American Association for Cancer Research (AACR) taking place April 14 – 19, 2023.
  • Natera and its collaborators will present findings from five studies on Signatera in esophago-gastric adenocarcinoma, muscle-invasive bladder cancer (MIBC), colorectal cancer (CRC) and hepatocellular carcinoma (HCC).
  • “These data presentations underscore Natera’s commitment to generating novel insights on MRD testing and genomic testing to help advance cancer care.”
    The full list of Signatera poster presentations at AACR is below.
  • Abstract #2178 | April 17, 9:00 AM - 12:30 PM
    Abstract #5600 | April 18, 1:30 - 5:00 PM
    Abstract #5591 | April 18, 1:30 - 5:00 PM
    Abstract #5604 | April 18, 1:30 - 5:00 PM
    Abstract #6696 | April 19, 9:00 AM - 12:30 PM